1.2. Pediatrics
The FDA requires that all antidepressant drugs display a black box warning describing the potential for increased suicidal thinking and behavior when prescribed to children and adolescents with MDD and other psychiatric disorders. In short-term clinical trials, the suicide risk occurred twice as frequently with antidepressant-treated children/adolescents compared to those receiving placebo (4% vs. 2%, respectively) in the first few months of treatment. Pediatric patients prescribed antidepressant drugs should be closely monitored for changes in behavior.
Citalopram and paroxetine are not FDA-approved for use in pediatric patients as safety and effectiveness in this age group have not been well established. The olanzapine/fluoxetine combination is FDA-approved in pediatric patients.
Maximum pediatric recommended doses for SSRI antidepressants approved for use as monotherapy and combination therapy are summarized in Tables 3 and 4, respectively. An additional column reflecting literature-based dosing included in the Texas Health and Human Services Psychotropic Medication Utilization Parameters for Children and Youth in Texas Public Behavioral Health (6th Version) is included in Tables 3 and 4. Dosages exceeding these recommendations will be reviewed.
Drug Name | Available Dosage Strengths | Treatment Indication | Literature Based Maximum Dosage | FDA Approved Maximum Recommended Dosage |
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citalopram (Celexa®) | 10 mg, 20 mg, 40 mg tablets; 30 mg capsule; 10 mg/ 5 mL oral solution |
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escitalopram (Lexapro®, generics) | 5 mg, 10 mg, 20 mg tablets; 5 mg/5 mL oral solution | MDD |
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fluoxetine (Prozac®, generics) | 10 mg, 20 mg, 40 mg capsules; 10 mg, 20 mg, 60 mg tablets; 20 mg/5 mL solution | MDD |
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OCD |
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fluoxetine (Prozac Pulvules®) | 10 mg, 20 mg, 40 mg pulvules | BD |
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MDD |
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OCD |
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fluvoxamine (generics) | IR: 25 mg, 50 mg, 100 mg tablets | OCD |
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Fluvoxamine controlled release (Luvox CR®, generics) | CR: 100 mg, 150 mg | OCD |
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sertraline (Zoloft®, generics) | 25 mg, 50 mg, 100 mg tablets; 20 mg/mL oral concentrate | OCD | Age greater than or equal to 6 years: 200 mg/day | 6 to 17 years of age: 200 mg/day |
Legend:
- BD = bipolar I disorder
- IR = immediate-release
- MDD = major depressive disorder
- OCD = obsessive-compulsive disorder
- # Fluvoxamine IR doses > 50 mg daily should be administered in divided doses, if the two doses are unequal the larger dose should be given at bedtime
- ^ In combination with olanzapine
Treatment Indication | Drug Name | Available Dosage Strengths | Literature Based Maximum Dosage | FDA Approved Maximum Recommended Dosage |
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BD | olanzapine/ fluoxetine (Symbyax®, generics) | 3 mg/ 25 mg, 6 mg/ 25 mg, 12 mg/25 mg, 6 mg/ 50 mg, 12 mg/ 50 mg capsules | Age 10-17 years: 12 mg olanzapine/50 mg fluoxetine once daily | 10 to 17 years of age: 12 mg/50 mg per day |
Legend:
- BD = bipolar I disorder